Depression and ART Adherence in HIV+ Latinos
|ClinicalTrials.gov Identifier: NCT01411839|
Recruitment Status : Unknown
Verified August 2011 by University of Washington.
Recruitment status was: Active, not recruiting
First Posted : August 8, 2011
Last Update Posted : August 24, 2011
|Condition or disease||Intervention/treatment|
|Depressive Symptoms HIV Infections||Behavioral: Cognitive-Behavioral Therapy AD|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||September 2011|
Experimental: Cognitive-Behavioral Therapy (CBT-AD)
CBT intervention for adherence and depression in a sample of HIV+ Latinos. The intervention is designed for issues of non-adherence and depressive symptomatology. Therapy intervention involves 10-weekly or biweekly sessions, with 2 booster session.
Behavioral: Cognitive-Behavioral Therapy AD
Therapeutic intervention, one-on-one and face-to-fact, over multiple sessions
Other Name: CBT-AD
No Intervention: Control-Standard Care
Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter is sent to their medical provider indicating that mild symptoms of depression were detected. The participants in the control arm are followed and matched to a participant in the intervention arm.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Changes in depression ratings at two time points: From baseline to 6 and 9 month follow-up ]The MADRS is a 10-item clinician administered scripted rating scale of depressive symptoms. The scale was develop to capture current depressive symptoms within the past seven days. The areas covered include: apparant and reported sadness, inner tension, reduced sleep and appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Both control and treatment conditions are interviewed with the MADRS at baseline and at 6 and 9 month follow-ups for any changes.
- Self-Report Adherence [ Time Frame: Changes in self-reported adherence from baseline through 9 months ]From the Visual Analogue Scale or brief items
- MedSignals Electronic Pill-box for Adherence [ Time Frame: Changes in adherence at two-time points: from baseline to 6 and 9 month follow-up ]The MedSignals electronic pill-box is a elecontric storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants of their dosing regimen. The pill-box stores adherence information (time, number of openings). In the control condition, the pill-box does not alarm participants. The pill-box serves as a storage bin for the control condition and stores adherence data. All data is then uploaded onto an online database for investigators.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411839
|United States, Texas|
|Centro de Salud Familiar La Fe CARE Center|
|El Paso, Texas, United States, 79925|
|Principal Investigator:||Jane M Simoni, Ph.D.||University of Washington|